FDA 510(k) Applications for Medical Device Product Code "LDT"
(Reagent, General Purpose)

FDA 510(k) Number Applicant Device Name Decision Date
K842863 ANATECH, LTD. PRO-SOFT DEHYDRANT 08/21/1984
K842934 E K IND., INC. DECOLORIZING FLUIC, ACID-ALCOHOL 3% 09/12/1984
K842729 E K IND., INC. DECOLORIZING FLUID 08/03/1984
K842070 INTERSCIENCE DIAGNOSTICS, INC. IDD DETERGENT 07/02/1984
K822326 INTERSCIENCE, INC. BLENDED DETERGENT-78N 1912-1 10/18/1982
K850845 MICRO MEDIA LABORATORIES 0.85% SALINE 03/20/1985
K831620 OMEGA MEDICAL DIAGNOSTICS SODIUM HYPOCHLORITE 3% 07/28/1983
K831619 OMEGA MEDICAL DIAGNOSTICS SODIUM HYPOCHLORITE 7% 07/28/1983
K863550 REAGENT LABORATORY, INC. POTASSIUM HYDROXIDE 10% W/V 10/02/1986
K871533 REMEL CO. TOMTEC GRAM STAINER DECOLORIZER 04/29/1987
K861890 RICHARD-ALLAN MEDICAL IND., INC. 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 06/03/1986
K811800 RICHARD-ALLAN MEDICAL IND., INC. BLUING REAGENT 08/12/1981
K811796 RICHARD-ALLAN MEDICAL IND., INC. FORMAL ALCOHOL 07/28/1981
K850737 ROSEVILLE MEDICAL LABORATORIESU TRANSPORT CULTURE MEDIUM 03/20/1985
K850916 SURGIPATH MEDICAL INDUSTRIES, INC. SPRAYFIX 03/25/1985
K822037 VOLU SOL MEDICAL INDUSTRIES VOLU-SOL TAP WATER SUBSTITUTE 08/03/1982


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